Flexible stent

ABSTRACT

The present invention is directed to a flexible expandable stent for implantation in a body lumen, such as a coronary artery. The stent generally includes a series of metallic cylindrical rings longitudinally aligned on a common axis of the stent and interconnected by a series of links which be polymeric or metallic. Varying configurations and patterns of the links and rings provides longitudinal and flexural flexibility to the stent while maintaining sufficient column strength to space the cylindrical rings along the longitudinal axis and providing a low crimp profile, enhanced stent security and radial stiffness.

BACKGROUND OF THE INVENTION

This invention relates to expandable endoprosthesis devices, generallyknown as stents, which are designed for implantation in a patient's bodylumen, such as arteries or blood vessels to maintain the patencythereof. These devices are particularly useful in the treatment andrepair of blood vessels after a stenosis has been compressed bypercutaneous transluminal coronary angioplasty (PTCA), or percutaneoustransluminal angioplasty (PTA), or removed by atherectomy or othermeans.

Stents are generally cylindrically-shaped devices which function to holdopen and sometimes expand a segment of a blood vessel or other lumensuch as a coronary artery.

A variety of devices are known in the art for use as stents and haveincluded balloon expandable stents having a variety of patterns; coiledwires in a variety of patterns that are expanded after being placedintraluminally on a balloon catheter; helically wound coiled springsmanufactured from an expandable heat sensitive metal; and self expandingstents inserted in a compressed state and shaped in a zigzag pattern.One of the difficulties encountered using prior stents involvedmaintaining the radial rigidity needed to hold open a body lumen whileat the same time maintaining the longitudinal flexibility of the stentto facilitate its delivery and accommodate the often tortuous path ofthe body lumen.

Another problem area has been the limiting range of expandability.Certain prior art stents expand only to a limited degree due to theuneven stresses created upon the stents during radial expansion. Thisnecessitates providing stents with a variety of diameters, thusincreasing the cost of manufacture. Additionally, having a stent with awider range of expandability allows the physician to redilate the stentif the original vessel size was miscalculated.

Another problem with the prior art stents has been contraction of thestent along its longitudinal axis upon radial expansion of the stent.This can cause placement problems within the artery during expansion.

Various means have been described to deliver and implant stents. Onemethod frequently described for delivering a stent to a desiredintraluminal location includes mounting the expandable stent on anexpandable member, such as a balloon, provided on the distal end of anintravascular catheter, advancing the catheter to the desired locationwithin the patient's body lumen, inflating the balloon on the catheterto expand the stent into a permanent expanded condition and thendeflating the balloon and removing the catheter.

What has been needed is a stent which has an enhanced degree offlexibility so that it can be readily advanced through tortuouspassageways and radially expanded over a wider range of diameters withminimal longitudinal contraction. The expanded stent must also of coursehave adequate structural strength (hoop strength) to hold open the bodylumen in which it is expanded. The present invention satisfies theseneeds.

SUMMARY OF THE INVENTION

The present invention is directed to stents having a high degree offlexibility along their longitudinal axis to facilitate delivery throughtortuous body lumens, but which remain highly stable when expandedradially, to maintain the patency of a body lumen such as an artery orother vessel when implanted therein. The unique patterns and materialsof the stents of the instant invention permit both greater longitudinalflexibility and enhanced radial expandability and stability compared toprior art stents.

Each of the different embodiments of stents of the present inventioninclude a plurality of adjacent cylindrical rings which are generallyexpandable in the radial direction and arranged in alignment along alongitudinal stent axis. At least one link extends between adjacentcylindrical rings and connects them to one another. The rings and linksmay each be formed with a variety of undulations containing a pluralityof alternating peaks and valleys. This configuration helps to ensureminimal longitudinal contraction during radial expansion of the stent inthe body lumen. The undulations of the rings and links contain varyingdegrees of curvature in regions of the peaks and valleys and are adaptedso that the radial expansion of the cylindrical rings are generallyuniform around their circumferences during expansion of the stents fromtheir contracted conditions to their expanded conditions.

The resulting stent structures are a series of radially expandablecylindrical rings which are spaced longitudinally close enough so thatsmall dissections in the wall of a body lumen may be pressed back intoposition against the luminal wall, but not so close as to compromise thelongitudinal flexibility of the stent both when being negotiated throughthe body lumens in their unexpanded state and when expanded intoposition. Upon expansion, each of the individual cylindrical rings mayrotate slightly relative to their adjacent cylindrical rings withoutsignificant deformation, cumulatively providing stents which areflexible along their length and about their longitudinal axis, but whichare still very stable in the radial direction in order to resistcollapse after expansion.

The presently preferred structures for the expandable cylindrical ringswhich form the stents of the present invention generally have aplurality of circumferential undulations containing a plurality ofalternating peaks and valleys where the rings are formed from a metallicmaterial. The links interconnecting the rings may also have undulationsand may be formed from a polymer or metal as well as being coated with apolymeric coating. In all embodiments, the series of links provide thestent with longitudinal and flexural flexibility while maintainingsufficient column strength to space the cylindrical rings along thelongitudinal axis. The metallic material forming the rings provides thestent with the necessary radial stiffness after the stent is implantedinto a body lumen.

In the case of a balloon expandable catheter system, the cylindricalrings and the links remain closely coupled from the time the stent iscrimped onto the delivery system to the time the stent is expanded andimplanted into a body lumen. Accordingly, the cylindrical rings havefirst delivery diameters in the crimped state of the stent and secondlarger implanted diameters in the expanded state of the stent.

The stent can generally be divided into three sections for illustrationpurposes. The sections include a proximal stent section, a center stentsection and a distal stent section. The proximal stent section includesone proximal ring and a series of corresponding proximal links. Theproximal links are attached to an adjacent center ring located in thecenter stent section. The center stent section includes a series ofcenter rings along with a series of center links interconnecting thecenter rings. The distal stent section includes a distal ring and aseries of distal links connected thereto. The distal links are alsoattached to an adjacent center ring in the center stent section.

The rings are each formed with circumferential undulations that may bedescribed as a series of peaks, valleys and straight portions. Forfurther clarification, each ring within the stent can be divided intothree sections including a proximal ring section, a center ring sectionand a distal ring section. The proximal ring section includes the peakswhile the distal ring section includes the valleys. In between the twosections the center ring section includes the straight portions.

The rings are aligned along the longitudinal axis and in the majority ofembodiments arranged so that adjacent rings have peaks aligned withvalleys. In this arrangement all adjacent rings are circumferentiallyoffset from each other (out of phase) along the longitudinal axis of thestent so that they appear to be mirror images of each other. Forexample, the proximal ring forms the proximal end of the stent andincludes valleys in its distal ring section. Adjacent the proximal ringis a center ring which is connected to the proximal rings with a seriesof proximal links as mentioned above. The proximal ring section of thiscenter ring includes peaks which are aligned with the valleys of theproximal ring. Accordingly, the valleys of this center ring are alignedwith the peaks of the adjacent center ring and so on for the length ofthe stent. In one embodiment mentioned below adjacent rings are out ofphase to a lesser degree such that two rings separate completely out ofphase rings.

The links interconnecting the adjacent rings may include straightportions and/or undulations. In all cases each link has a proximal linkend and a distal link end. The proximal link end is attached to a distalsection of one ring while the distal link end is attached to a proximalsection of another adjacent ring.

In one embodiment, four links interconnect each pair of adjacent ringswithin the distal stent section and the proximal stent section whilefive links interconnect adjacent rings in the center stent section. Ofthese links, two (three in center section) are substantially straightand the remaining two links are more flexible with loop shapes andsmaller cross-sectional areas. The two types of links are alternatelyarranged around the circumference of the stent so that the rigidityprovided by the straight links is sufficiently offset by the flexibilityprovided by the loop-shaped links. The rings each include ten peaks andten valleys and the loop-shaped rings between adjacent rings helps toprevent clamshell opening. Clamshell opening occurs when a stent isexpanded and a portion of the stent between two adjacent rings separatesabnormally. This abnormal operation may cause undesirable effects suchas tissue prolapse, movement of the stent within a vessel and reducedcoverage area.

In another embodiment three links interconnect each pair of adjacentrings rather than four and five links as discussed in the embodimentabove. The rings also have nine peaks rather than ten as above. In thisconfiguration, the links essentially couple every third undulationbetween adjacent rings. The links are all formed substantially straightrather than loop-shaped. The use of three links for every pair ofadjacent rings provides uniform flexibility around the circumference ofthe stent.

In another embodiment adjacent rings are circumferentially offset withrespect to each other along the longitudinal axis. The rings each havenine peaks and are offset such that two rings separate completely out ofphase rings. Three links couple each pair of adjacent rings to reducepotential clamshell opening.

In another embodiment the rings each have ten peaks and adjacent ringsare coupled by three links in the center stent section. The rings withinthe proximal stent section include undulations that, while beinggenerally U-shaped, have curvatures incorporated therein to help retainthe stent onto a delivery catheter. In the distal stent section andproximal stent section two rather than three links couple the rings tothe center rings of the center stent section.

In all embodiments the rings and links may include reservoirs to retaintherapeutic drugs. The reservoirs may be formed as either micro-channelsor micro-depots within the rings or links. The material of the rings orlinks associated with these reservoirs may be either a polymer or ametal.

Each of the embodiments of the invention can be readily delivered to thedesired luminal location by mounting them on an expandable member of adelivery catheter, for example a balloon, and passing the catheter-stentassembly through the body lumen to the implantation site. A variety ofmeans for securing the stents to the expandable member on the catheterfor delivery to the desired location are available. It is presentlypreferred to crimp the stent onto the unexpanded balloon. Other means tosecure the stent to the balloon include providing ridges or collars onthe inflatable member to restrain lateral movement, using bioabsorbabletemporary adhesives, or a retractable sheath to cover the stent duringdelivery through a body lumen.

While the cylindrical rings and links incorporated into the stent aregenerally not separate structures when both are formed from a metallicmaterial, they have been conveniently referred to as rings and links forease of identification. Further, the cylindrical rings can be thought ofas comprising a series of U-shaped structures in a repeating pattern.While the cylindrical rings are not divided up or segmented intoU-shaped structures, the pattern of cylindrical rings resemble suchconfiguration. The U-shaped structures promote flexibility in the stentprimarily by flexing and may tip radially outwardly as the stent isdelivered through a tortuous vessel.

The links which interconnect adjacent cylindrical rings can havecross-sections smaller, larger or similar to the cross-sections of theundulating components of the cylindrical rings. The links may be formedin a unitary structure with the expandable cylindrical rings, or theymay be formed independently and mechanically secured between theexpandable cylindrical rings. The links may be formed substantiallylinearly or with a plurality of undulations.

Preferably, the number, shape and location of the links can be varied inorder to develop the desired coverage area and longitudinal flexibility.These properties are important to minimize alteration of the naturalphysiology of the body lumen into which the stent is implanted and tomaintain the compliance of the body lumen which is internally supportedby the stent. Generally, the greater the longitudinal flexibility of thestents, the easier and the more safely they can be delivered to theimplantation site, especially where the implantation site is on a curvedsection of a body lumen, such as a coronary artery or a peripheral bloodvessel, and especially saphenous veins and larger vessels.

The stent may be formed from a tube by laser cutting the pattern ofcylindrical rings and links in the tube, by individually forming wirerings and laser welding them together, and by laser cutting a flat metalsheet in the pattern of the cylindrical rings and links and then rollingthe pattern into the shape of the tubular stent and providing alongitudinal weld to form the stent.

Other features and advantages of the present invention will become moreapparent from the following detailed description of the invention, whentaken in conjunction with the accompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevational view, partially in section, of a stentembodying features of the invention which is mounted on a deliverycatheter and disposed within a damaged artery.

FIG. 2 is an elevational view, partially in section, similar to thatshown in FIG. 1 wherein the stent is expanded within a damaged ordiseased artery.

FIG. 3 is an elevational view, partially in section, depicting theexpanded stent within the artery after withdrawal of the deliverycatheter.

FIG. 4 is a perspective view of the stent of FIG. 3 in its expandedstate depicting the undulating pattern along the peaks and valleys thatform the cylindrical rings.

FIG. 5 is a plan view of a flattened section of the embodiment shown inFIGS. 1-4.

FIG. 6 is a plan view of a flattened section of one embodiment of astent of the invention incorporating nine peaks within each ring.

FIG. 7 is a plan view of a flattened section of one embodiment of astent of the invention incorporating circumferentially offset rings.

FIG. 8 is a plan view of a flattened section of one embodiment of astent of the invention incorporating a modified U-shaped undulating ringwithin the proximal stent section.

FIG. 8A is a cross-sectional view of a curved portion of the proximalrings shown in FIG. 8.

FIG. 9 is a plan view of a flattened section of one embodiment of astent of the invention incorporating rings with micro-depots andmicro-channels.

FIG. 10 is a plan view of a flattened section of one embodiment of astent of the invention incorporating links with micro-depots andmicro-channels.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Before describing in detail an exemplary embodiment of a stent inaccordance with the present invention, it is instructive to brieflydescribe a typical stent implantation procedure and the vascularconditions which are typically treated with stents. Referring now toFIG. 1, a stent 10 of the present invention is shown mounted on acatheter 11 having a lumen 19 and an inflation member (balloon) 14. Thestent and catheter are shown inside the lumen of an arterial vessel 16.The stent is shown positioned across a small amount of arterial plaque15 adhering to the lumen of the artery. In some procedures, a stent isdirectly implanted without a prior procedure, such as balloonangioplasties. In other procedures, the plaque is the remainder of anarterial lesion which has been previously dilated or radially compressedagainst the walls of the artery, or has been partially removed from theartery. Lesion dilation is typically accomplished by an angioplastyprocedure, while lesion removal is typically accomplished by anatherectomy procedure. These and other procedures for the treatment ofarterial lesions are well known to those skilled in the art.

With most lesion treatment procedures, the treated artery suffers adegree of trauma, and in a certain percentage of cases may abruptlycollapse or may slowly narrow over a period of time due to neointimalhyperplasia which is referred to as restenosis. To prevent either ofthese conditions, the treated artery is often fitted with a prostheticdevice, such as the stent 10 of the present invention. The stentprovides radial support for the treated vessel and thereby preventscollapse of the vessel 16, and further provides scaffolding to preventplaque prolapse within the lumen. The stent may also be used to repairan arterial dissection, or an intimal flap, both of which are sometimesfound in the coronary arteries, peripheral arteries and other vessels.In order to perform its function, the stent must be accurately placedacross the lesion site. Therefore, it is critical that the stent besufficiently radiopaque so that the physician can visually locate thestent under fluoroscopy during the implantation procedure. However, itis equally important that the stent not be too radiopaque. If the stentis overly radiopaque, i.e., too bright, the physician's view of thelumen is compromised. This makes assessment of subsequent restenosisdifficult. In cases where balloon markers are very close to the stent,the stent can blend in with the markers. Without precise visualizationof the stent ends, accurate placement of the stent in a lesion,particularly in the case of an ostial lesion, can be compromised.

With continued reference to FIG. 1, in a typical stent placementprocedure, a guiding catheter (not shown) is percutaneously introducedinto the cardiovascular system of a patient through the femoral arteriesby means of a conventional Seldinger technique, and advanced within apatient's vascular system until the distal end of the guiding catheteris positioned at a point proximal to the lesion site. A guide wire andthe stent-delivery catheter 11 of the rapid exchange type are introducedthrough the guiding catheter with the guide wire sliding within thestent-delivery catheter. The guide wire is first advanced out of theguiding catheter into the arterial vessel 16 and is advanced across thearterial lesion. Prior to implanting the stent, the cardiologist maywish to perform an angioplasty or other procedure (e.g., atherectomy) inorder to open and remodel the vessel and the diseased area.

Referring to FIG. 2, the stent delivery catheter assembly 11 is advancedover the guide wire so that the stent 10 is positioned in the targetarea. The stent-delivery catheter is subsequently advanced over thepreviously positioned guide wire until the stent is properly positionedacross the lesion.

Referring now to FIGS. 2 and 3, once in position, the dilation balloon14 is inflated to a predetermined size to radially expand the stent 10against the inside of the artery wall and thereby implant the stentwithin the lumen of the artery 16. The balloon 14 is then deflated to asmall profile so that the stent- delivery catheter may be withdrawn fromthe patient's vasculature and blood flow resumed through the artery.

The metallic cylindrical rings 12 of this embodiment are formed fromtubular members and may be relatively flat in transverse cross-section.Thus, after implantation into the artery 16 as shown in FIG. 3, minimalinterference with blood flow occurs. Eventually the stent becomescovered with endothelial cell growth, which further minimizes blood flowinterference. As should be appreciated by those skilled in the art that,while the above-described procedure is typical, it is not the onlymethod used in placing stents.

The stent patterns shown in FIGS. 1-3 are for illustration purposes onlyand can vary in size and shape to accommodate different vessels or bodylumens. Further, the stent 10 is of a type that can be used inaccordance with the present invention.

Links 18,21 interconnect adjacent cylindrical rings 12 and may havecross-sections smaller, larger or similar to the cross-sections of theundulating components of the expandable cylindrical rings. The numberand location of the links connecting the rings together can be varied inorder to vary the desired longitudinal and flexural flexibility in thestent assembly structure in the unexpanded as well as expanded conditionof the stent. These properties are important to minimize alteration ofthe natural physiology of the body lumen into which the stent assemblyis implanted and to maintain the compliance of the body lumen which isinternally supported by the stent assembly. Generally, the greater thelongitudinal and flexural flexibility of the stent assembly, the easierand the more safely it can be delivered to the target site.

With reference to FIG. 4, the stent 10 includes cylindrical rings 12 inthe form of undulating portions. The undulating portions are made up ofa plurality of U-shaped undulations 20 having radii that more evenlydistribute expansion forces over the various members. After thecylindrical rings have been radially expanded, outwardly projectingedges 22 may be formed. That is, during radial expansion some of theU-shaped undulations may tip radially outwardly thereby formingoutwardly projecting edges. These outwardly projecting edges can providefor a roughened outer wall surface of the stent and assist in implantingthe stent in the vascular wall by embedding into the vascular wall. Inother words, the outwardly projecting edges may embed into the vascularwall, for example arterial vessel 16, as depicted in FIG. 3. Dependingupon the dimensions of the stent and the thickness of the variousmembers making up the serpentine pattern, any of the U-shapedundulations may tip radially outwardly to form the projecting edges.

The cylindrical rings 12 can be nested such that adjacent rings slightlyoverlap in the longitudinal direction so that one ring is slightlynested within the next ring and so on. The degree of nesting can bedictated primarily by the length of each link, cylindrical ring, thenumber of undulations in the rings, the thickness of the rings, and theradius of curvature, of the rings all in conjunction with the crimped ordelivery diameter of the stent. If the rings are substantially nestedone within the other, it may be difficult to crimp the stent to anappropriate delivery diameter without the various struts overlapping. Itis also contemplated that the rings may be slightly nested even afterthe stent is expanded, which enhances vessel wall coverage. In somecircumstances, it may not be desirable to nest one ring within theother, which is also contemplated by the invention.

For the purpose of illustration only, the stent 10 is shown as a flatpattern in FIG. 5 so that the pattern of rings 12 and links 18,21 may beclearly viewed. Normally the stent of the present invention is formed ofa cylindrical structure, however, it is beneficial to describe variousparts to facilitate discussion. The rings in the present embodiment havean undulating shape including peaks 42 and valleys 44 formed as U-shapedundulations 20 which are out of phase with the U-shaped undulations ofadjacent cylindrical rings. The particular pattern and how manyundulations, or the amplitude of the undulations, are chosen to fillparticular mechanical requirements for the stent, such as radialstiffness and longitudinal flexibility. Typically, each adjacent ringwill be connected by at least one connecting link 18,21. The number ofcylindrical rings incorporated into the stent can also vary according todesign requirements taking into consideration factors such as radialstiffness and longitudinal flexibility.

The substantially straight links 18 also can be formed with anundulating pattern to enable the stent to have higher flexibility anddeliverability and may be formed in a number of different patternsaccording to design requirements. For example, the links can be formedwith more or less surface area, larger or smaller cross-sections, curvesor oscillations, and a variety of other shapes according to designrequirements.

The stent patterns shown in FIGS. 1-5 are for illustration purposes onlyand can vary in shape and size to accommodate different vessels or bodylumens. Thus, rings 12 connected by links 18,21 can have any structuralshapes and are not limited to the aforedescribed undulating ringsincluding U-shaped portions. Links connecting the rings can also includeoscillating patterns, sinusoidal patterns and zig-zag patterns. Oneaspect of the invention also provides for various anchoring mechanismsfor attaching the links to the rings.

For illustration purposes an embodiment of the stent of the presentinvention shown in FIGS. 1-5 can generally be divided into a proximalstent section 24, a center stent section 26 and a distal stent section28. The proximal stent section includes one proximal ring 30 and aseries of corresponding proximal links 32,33. The proximal links areattached to a center ring 34 located in the center stent section. Thecenter stent section includes other center rings and center links 36,37interconnecting the center rings. The distal stent section includes adistal ring 38 and a series of distal links 40,41 connected thereto.Like the proximal links the distal links are attached to a center ring.

As shown in FIG. 5, adjacent rings 12 are arranged out of phase alongthe longitudinal axis of the stent so that adjacent rings have peaks 42aligned with valleys 44. In this arrangement all adjacent rings appearto be mirror images of each other and out of phase. For example, theproximal ring 30 includes distal valleys and adjacent the proximal ringis a center ring 34 with proximal peaks. The peaks of the center ringare aligned with the valleys of the proximal ring so that these adjacentrings appear to be mirror images of each other. Accordingly, the valleysof this center ring are aligned with the peaks of the adjacent centerring and so on for the length of the stent.

In this embodiment embodiment the stent includes two types of links18,21. The substantially straight links are important for maintainingthe structural integrity of the stent and three of these links are usedbetween adjacent center rings 34 to reduce potential clamshell opening.Clamshell opening may occur upon expansion of the stent when less thanthree links are used for every pair of adjacent rings. The loop-shapedlinks with relatively smaller cross-sectional areas also help tominimize the clamshell opening effect while minimally reducing theflexibility of the stent. In the proximal stent section 24 and distalstent section 28 two substantially straight links are utilized tomaintain flexibility while two loop-shaped links are used between everypair of adjacent rings throughout the stent.

In another embodiment shown in FIG. 6, a stent 64 includes links 66which are all substantially straight and similarly sized. The rings 62each incorporate undulations with nine peaks 68 rather than ten peaks 42as in the embodiment shown in FIGS. 1-5. With a smaller number ofundulations, there is more area between the peaks and valleys on eachring. The increased open area allows a delivery balloon to penetrate thestent farther when the stent is crimped onto a delivery catheter. Thishigh degree of penetration helps to securely retain the stent. The linksconnect every third peak and valley of adjacent rings and are spacedevenly around the circumference of the stent to uniformly distributeload. The links also are circumferentially offset along the longitudinalaxis of the stent so that flexibility is maximized.

In another embodiment shown in FIG. 7, a stent 84 includes undulatingrings 86 that are circumferentially offset from each other along thelongitudinal axis of the stent to a lesser degree than the rings in FIG.6. The offset is such that two rings separate completely out of phaserings. In the proximal stent section 88 and the distal stent section 92two links interconnect adjacent rings while in the center stent section90 three links 94 interconnect adjacent rings. This configuration oflinks maximizes rigidity and minimizes the clamshell opening effectwithin the center stent section. The rings 86 each incorporate ninepeaks 96 which help offset the rigidity provided by the three links forevery pair of adjacent ring within the center section and thecircumferential offset of the rings along the longitudinal axis. As inthe embodiment shown in FIG. 6, the links are circumferentially offsetalong the longitudinal axis to enhance flexibility. The space betweenthe nine peaks within the rings of the present embodiment also enablesthe stent to have improved retention on the delivery catheter similar tothe embodiment shown in FIG. 7.

In another embodiment shown in FIG. 8, a stent 98 includes modifiedU-shaped undulations 100 within the proximal ring 101 of the proximalstent section 102 while the center section 104 incorporates U-shapedundulations 105 as in FIGS. 1-7. The modified undulations include aseries of curves 108 therein to help retain the stent onto the deliverycatheter. More particularly, the curves allow the delivery balloon to besecurely held within the rings and therefore help to prevent movement ofthe stent with respect to the balloon. As shown in detail in FIG. 8A,the proximal ring includes a proximal ring section 116, a center ringsection 118 and a distal ring section 119. The curved portion of themodified U-shaped undulation is located in the center ring section whilethe proximal ring section and the distal ring section are substantiallysimilar to those of the U-shaped undulations in the center stent sectionand distal stent section. Two links 112,114 are used to couple adjacentrings in the proximal stent section and the distal stent section whilethree links 110 are used in the center stent section to connect everyadjacent ring. Due to the relatively small number of links coupling theproximal ring and the distal ring to the center rings, flexibility forthis configuration is high within the distal stent section and proximalstent section while the center stent section retains a higher degree ofrigidity.

In another embodiment shown in FIG. 9, therapeutic drugs can beuniformly loaded and distributed through reservoirs in the proximal ring122 and in the distal ring 124 to help prevent restenosis within theproximal stent section 126 and distal stent section 128 of a stent 120.More particularly, the proximal ring incorporates micro-channels 130within its structure to help retain the therapeutic drug. Similarly, thedistal ring incorporates micro-depots 132 which also help to retain thetherapeutic drug. For illustration purposes both types of reservoirs areshown in the embodiment of FIG. 9 while in practice either or both maybe incorporated into the stent. Additionally, either type of reservoircan be used on other rings within the stent and can be incorporated intothe other embodiments as needed. For example, the micro-channels may beincorporated into the distal rings and the micro-depots may beincorporated into the proximal rings.

In the embodiment shown in FIG. 10, a stent 134 includes reservoirswithin the proximal links 136 and the distal links 138 similar to thosein the proximal ring 122 and the distal ring 124 of the embodiment shownin FIG. 9. More particularly this embodiment includes two links withinthe proximal stent section 140 incorporating micro-depots and two distallinks within the distal section 142 incorporating micro-channels, bothof which help to uniformly retain and distribute a therapeutic drug. Forillustration purposes both types of reservoirs are shown in theembodiment of FIG. 10 while in practice either or both may beincorporated into the stent. Additionally, either type of reservoir canbe used on other links within the stent and can be incorporated into theother embodiments as needed. For example, the micro-channels may beincorporated into the proximal links and the micro-depots may beincorporated into the distal links.

In keeping with the invention, the links of any embodiment may be formedfrom a flexible polymeric material, that is bendable and flexible toenhance longitudinal and flexural flexibility of the stent. Thepolymeric material forming the links can be taken from the group ofpolymers consisting of polyurethanes, polyolefins, polyesters,polyamides, flouropolymers and their co-polymers, polyetherurethanes,polyesterurethanes, silicone, thermoplastic elastomer (C-flex),polyether-amide thermoplastic elastomer (Pebax), fluoroelastomers,fluorosilicone elastomer, polydimethyl siloxones (PDMS), aromatic PDMS,silicon thermoplastic urethanes, poly (glycerol-sebacate) (PGS)(developed by Yadong Wang, MIT) and commonly referred to as biorubber,styrene-butadiene rubber, butadiene-styrene rubber, polyisoprene,neoprene (polychloroprene), ethylene-propylene elastomer,chlorosulfonated polyethylene elastomer, butyl rubber, polysulfideelastomer, polyacrylate elastomer, nitrile, rubber, a family ofelastomers composed of styrene, ethylene, propylene, aliphaticpolycarbonate polyurethane, polymers augmented with antioxidents,polymers augmented with image enhancing materials, polymers having aproton (H+) core, polymers augmented with protons (H+), butadiene andisoprene (Kraton), polyester thermoplastic elastomer (Hytrel),methacrylates, ethylene, acetate, alcohol, and polyvinyl alcohol.

The rings and the links (when metallic) may be made of suitablebiocompatible material such as stainless steel, titanium, tungsten,tantalum, vanadium, cobalt chromium, gold, palladium, platinum, andiradium, and even high strength thermoplastic polymers. The stentdiameters are very small, so the tubing from which they are made mustnecessarily also have a small diameter. For PTA applications, typicallythe stent has an outer diameter on the order of about 1.65 mm (0.065inch) in the unexpanded condition, the same outer diameter of the tubingfrom which it is made, and can be expanded to an outer diameter of 5.08mm (0.2 inch) or more. The wall thickness of the tubing is about 0.076mm (0.003 inch). In the case of forming the stent from cobalt-chromiumthe wall thickness of the tubing may be reduced. For stents implanted inother body lumens, such as PTA applications, the dimensions of thetubing are correspondingly larger. While it is preferred that the stentsbe made from laser cut tubing, those skilled in the art will realizethat the stent can be laser cut from a flat sheet and then rolled up ina cylindrical configuration with the longitudinal edges welded to form acylindrical member.

The rings may also be made of materials such as super-elastic (sometimescalled pseudo-elastic) nickel-titanium (NiTi) alloys. In this case therings would be formed full size but deformed (e.g. compressed) to asmaller diameter onto the balloon of the delivery catheter to facilitateintraluminal delivery to a desired intraluminal site. The stress inducedby the deformation transforms the rings from an austenite phase to amartensite phase, and upon release of the force when the stent reachesthe desired intraluminal location, allows the stent to expand due to thetransformation back to the more stable austenite phase. Further detailsof how NiTi super-elastic alloys operate can be found in U.S. Pat. Nos.4,665,906 (Jervis) and 5,067,957 (Jervis). The NiTi alloy rings may beattached to the other rings through welding, bonding and other wellknown types of attachments.

The stent of the invention also can be coated with a drug or therapeuticagent. Further, it is well known that the stent (when both the rings andlinks are made from metal) may require a primer material coating such asa polymer to provide a substrate on which a drug or therapeutic agent iscoated since some drugs and therapeutic agents do not readily adhere toa metallic surface. The drug or therapeutic agent can be combined with acoating or other medium used for controlled release rates of the drug ortherapeutic agent. Representative examples of polymers that can be usedto coat a stent in accordance with the present invention includeethylene vinyl alcohol copolymer (commonly known by the generic nameEVOH or by the trade name EVAL), poly(hydroxyvalerate); poly(L-lacticacid); polycaprolactone; poly(lactide-co-glycolide);poly(hydroxybutyrate); poly(hydroxybutyrate-co-valerate); polydioxanone;polyorthoester; polyanhydride; poly(glycolic acid); poly(D,L-lacticacid); poly(glycolicacid-co-trimethylene carbonate); polyphosphoester;polyphosphoester urethane; poly(amino acids); cyanoacrylates;poly(trimethylene carbonate); poly(iminocarbonate); copoly(ether-esters)(e.g. PEO/PLA); polyalkylene oxalates; polyphosphazenes; biomolecules,such as fibrin, fibrinogen, cellulose, starch, collagen and hyaluronicacid; polyurethanes; silicones; polyesters; polyolefins; polyisobutyleneand ethylene-alphaolefin copolymers; acrylic polymers and copolymers;vinyl halide polymers and copolymers, such as polyvinyl chloride;polyvinyl ethers, such as polyvinyl methyl ether; polyvinylidenehalides, such as polyvinylidene fluoride and polyvinylidene chloride;polyacrylonitrile; polyvinyl ketones; polyvinyl aromatics, such aspolystyrene; polyvinyl esters, such as polyvinyl acetate; copolymers ofvinyl monomers with each other and olefins, such as ethylene-methylmethacrylate copolymers, acrylonitrile-styrene copolymers, ABS resins,and ethylene-vinyl acetate copolymers; polyamides, such as Nylon 66 andpolycaprolactam; alkyd resins; polycarbonates; polyoxymethylenes;polyimides; polyethers; epoxy resins; polyurethanes;polybutylmethacrylate; rayon; rayon-triacetate; poly(glycerol-sebacate);cellulose acetate; cellulose butyrate; cellulose acetate butyrate;cellophane; cellulose nitrate; cellulose propionate; cellulose ethers;and carboxymethyl cellulose.

“Solvent” is a liquid substance or composition that is compatible withthe polymer and is capable of dissolving the polymer at theconcentration desired in the composition. Representative examples ofsolvents include chloroform, acetone, water (buffered saline),dimethylsulfoxide (DMSO), propylene glycol methyl ether (PM,)iso-propylalcohol (IPA), n-propylalcohol, methanol, ethanol,tetrahydrofuran (THF), dimethylformamide (DMF), dimethyl acetamide(DMAC), benzene, toluene, xylene, hexane, cyclohexane, heptane, octane,pentane, nonane, decane, decalin, ethyl acetate, butyl acetate, isobutylacetate, isopropyl acetate, butanol, diacetone alcohol, benzyl alcohol,2-butanone, cyclohexanone, dioxane, methylene chloride, carbontetrachloride, tetrachloroethylene, tetrachloro ethane, chlorobenzene,1,1,1-trichloroethane, formamide, hexafluoroisopropanol,1,1,1-trifluoroethanol, and hexamethyl phosphoramide and a combinationthereof. The therapeutic substance contained in the coating can be forinhibiting the activity of vascular smooth muscle cells. Morespecifically, the therapeutic substance can be aimed at inhibitingabnormal or inappropriate migration and/or proliferation of smoothmuscle cells for the inhibition of restenosis. The therapeutic substancecan also include any active agent capable of exerting a therapeutic orprophylactic effect in the practice of the present invention. Forexample, the therapeutic substance can be for enhancing wound healing ina vascular site or improving the structural and elastic properties ofthe vascular site. Examples of therapeutic agents or drugs that aresuitable for use with the polymeric materials include sirolimus,everolimus, actinomycin D (ActD), taxol, paclitaxel, or derivatives andanalogs thereof. Examples of agents include other antiproliferativesubstances as well as antineoplastic, antiinflammatory, antiplatelet,anticoagulant, antifibrin, antithrombin, antimitotic, antibiotic, andantioxidant substances. Examples of antineoplastics include taxol(paclitaxel and docetaxel). Further examples of therapeutic drugs oragents that can be combined with the polymeric materials includeantiplatelets, anticoagulants, antifibrins, antithrombins, andantiproliferatives. Examples of antiplatelets, anticoagulants,antifibrins, and antithrombins include, but are not limited to, sodiumheparin, low molecular weight heparin, hirudin, argatroban, forskolin,vapiprost, prostacyclin and prostacyclin analogs, dextran,D-phe-pro-arg-chloromethylketone (synthetic antithrombin), dipyridamole,glycoprotein IIb/IIIa platelet membrane receptor antagonist, recombinanthirudin, thrombin inhibitor (available from Biogen located in Cambridge,Mass.), and 7E-3B® (an antiplatelet drug from Centocor located inMalvern, Pa.). Examples of antimitotic agents include methotrexate,azathioprine, vincristine, vinblastine, fluorouracil, adriamycin, andmutamycin. Examples of cytostatic or antiproliferative agents includeangiopeptin (a somatostatin analog from Ibsen located in the UnitedKingdom), angiotensin converting enzyme inhibitors such as Captopril®(available from Squibb located in New York, N.Y.), Cilazapril®(available from Hoffman-LaRoche located in Basel, Switzerland), orLisinopril® (available from Merck located in Whitehouse Station, N.J.);calcium channel blockers (such as Nifedipine), colchicine, fibroblastgrowth factor (FGF) antagonists, fish oil (omega 3-fatty acid),histamine antagonists, Lovastatin® (an inhibitor of HMG-CoA reductase, acholesterol lowering drug from Merck), methotrexate, monoclonalantibodies (such as PDGF receptors), nitroprusside, phosphodiesteraseinhibitors, prostaglandin inhibitor (available from GlaxoSmithKlinelocated in United Kingdom), Seramin (a PDGF antagonist), serotoninblockers, steroids, thioprotease inhibitors, triazolopyrimidine (a PDGFantagonist), and nitric oxide. Other therapeutic drugs or agents whichmay be appropriate include alpha-interferon, genetically engineeredepithelial cells, and dexamethasone.

While the foregoing therapeutic agents have been used to prevent ortreat restenosis, they are provided by way of example and are not meantto be limiting, since other therapeutic drugs may be developed which areequally applicable for use with the present invention. The treatment ofdiseases using the above therapeutic agents are known in the art.Furthermore, the calculation of dosages, dosage rates and appropriateduration of treatment are previously known in the art.

The stent of the present invention can be made in many ways. One methodof making the stent is to cut a tubular member, such as stainless steeltubing to remove portions of the tubing in the desired pattern for thestent, leaving relatively untouched the portions of the metallic tubingwhich are to form the stent. In accordance with the invention, it ispreferred to cut the tubing in the desired pattern by means of amachine-controlled laser as is well known in the art.

After laser cutting the stent pattern the stents are preferablyelectrochemically polished in an acidic aqueous solution such as asolution of ELECTRO-GLO#300, sold by ELECTRO-GLO Co., Inc. in Chicago,Ill., which is a mixture of sulfuric acid, carboxylic acids, phosphates,corrosion inhibitors and a biodegradable surface active agent. Otherelectropolishing solutions are well known in the art. The stents may befurther treated if desired, for example by applying a biocompatiblecoating.

Other methods of forming the stent of the present invention can be used,such as chemical etching; electric discharge machining; laser cutting aflat sheet and rolling it into a cylinder; and the like, all of whichare well known in the art at this time.

The stent of the present invention also can be made from metal alloysother than stainless steel, such as shape memory alloys. Shape memoryalloys are well known and include, but are not limited to,nickel-titanium and nickel/titanium/vanadium. Any of the shape memoryalloys can be formed into a tube and laser cut in order to form thepattern of the stent of the present invention. As is well known, theshape memory alloys of the stent of the present invention can includethe type known as thermoelastic martensitic transformation, or displaystress-induced martensite. These types of alloys are well known in theart and need not be further described here.

Importantly, a stent formed of shape memory alloys, whether thethermoelastic or the stress-induced martensite-type, can be deliveredusing a balloon catheter of the type described herein, or in the case ofstress induced martensite, be delivered via a catheter without a balloonor a sheath catheter.

While the invention has been illustrated and described herein, in termsof its use as an intravascular stent, it will be apparent to thoseskilled in the art that the stent can be used in other body lumens.Further, particular sizes and dimensions, number of peaks per ring,materials used, and the like have been described herein and are providedas examples only. Other modifications and improvements may be madewithout departing from the scope of the invention.

1-46. (canceled)
 47. An intravascular stent, comprising: a plurality of undulating rings including a proximal end ring, a distal end ring, and a plurality of center section rings therebetween, each ring having nine peaks on a proximal end of the ring and nine valleys on a distal end of the ring and adjacent rings are circumferentially offset from each other; a plurality of links connecting a valley of one ring to a peak of an adjacent ring, each of the plurality of links extending at an angle relative to a longitudinal axis of the stent; the proximal end ring is connected to an adjacent one of the center section rings by only two links; each pair of adjacent center section rings being connected by three links extending from a peak on the proximal end of one center section ring to an adjacent valley on the distal end of an adjacent center section ring; and the distal end ring is connected to an adjacent one of the center section rings by only two links.
 48. The intravascular stent of claim 47, wherein the angle formed between the links and the longitudinal axis of the stent is identical for all links.
 49. The intravascular stent of claim 48, wherein the angle formed between the links and the longitudinal axis of the stent is at the same orientation for all links.
 50. The intravascular stent of claim 47, wherein the links have a width that is greater than a width of the peaks and the valleys.
 51. The intravascular stent of claim 47, wherein the undulating rings have a cross-section different than a cross-section of the links.
 52. The intravascular stent of claim 47, wherein the peaks and the valleys are connected by bar arms, the bar arms having a width smaller than a width of the links.
 53. The intravascular stent of claim 47, wherein the stent is self-expanding expanding and formed from a nickel-titanium alloy.
 54. The intravascular stent of claim 47, wherein the stent is biodegradable.
 55. The intravascular stent of claim 47, wherein the stent includes a material therein to enhance the radiopacity of the stent.
 56. The intravascular stent of claim 47, wherein the undulating rings are formed from a metal selected from the group consisting of stainless steel, titanium, tungsten, tantalum, vanadium, nickel-titanium, cobalt-chromium, gold, palladium, platinum and platinum-iridium.
 57. The intravascular stent of claim 47, wherein at least a portion of the stent is coated with a therapeutic drug.
 58. The intravascular stent of claim 47, wherein at least one of the links include micro depots for accepting a therapeutic drug. 